California Attorney General Xavier Becerra announced a $120 million nationwide settlement with Johnson & Johnson and its subsidiaries, Medical Device Business Services, Inc., DePuy Products, Inc., DePuy Synthes, Inc., and DePuy Synthes Sales, Inc. (Johnson & Johnson). The settlement — of which California will receive $8 million — resolves allegations that the company violated state consumer protection laws by misrepresenting the effectiveness and safety of its hip implant devices. The multistate settlement alleges that Johnson & Johnson conducted unfair and deceptive marketing practices by making misleading claims on the longevity — also known as survivorship — of its metal-on-metal hip implant devices. Johnson & Johnson has also agreed to injunctive terms to reform how it markets and promotes its hip implant products.
“Johnson & Johnson is alleged to have deceived vulnerable patients in need of hip replacement and undermined their ability to recuperate quickly and safely,” said Attorney General Becerra. “The company allegedly deceived consumers by circulating misleading research and ignoring up-to-date information about the effectiveness of its devices. There’s no excuse for Johnson & Johnson to have violated its customers’ trust, as well as California consumer protection laws, but we worked to hold them accountable.”
The multistate settlement resolves allegations that Johnson & Johnson violated state law by misleading consumers in the marketing of metal-on-metal hip implant devices used for hip replacement surgeries. In 2005, Johnson & Johnson began marketing its ASR XL device to doctors seeking to provide longer-lasting hip replacement surgery in younger, more active patients. Johnson & Johnson actively and falsely advertised the product’s stability and survivorship as part of its “Never Stop Moving” campaign, citing an implant survivorship of nearly 100 percent after five years. Johnson & Johnson also misrepresented the implant survivorship of another hip implant device, the Pinnacle Ultamet, relying upon a questionable 2007 study that was advertised as independent, but designed by Johnson & Johnson. After receiving hip implants using these products, some consumers experienced painful side effects from the products, including persistent groin pain, allergy, tissue necrosis, as well as a build-up of metal ions in the blood.
As part of the settlement, Johnson & Johnson will pay $120 million in penalties, and comply with a set of important injunctive terms that are enforceable by the California Attorney General in the event of future misconduct. Under the consent judgement, the Johnson & Johnson subsidiary companies that market these devices will:
- Base claims of survivorship, stability or dislocations on scientific information and the most recent dataset available from a registry for any DePuy hip implant device;
- Maintain a post-market surveillance program and complaint handling program;
- Update and maintain internal product complaint handling operating procedures, including training of complaint reviewers;
- Update and maintain processes and procedures to track and analyze product complaints that do not meet the definition of Medical Device Reportable Events;
- Maintain a quality assurance program that includes an audit procedure for tracking complaints regarding DePuy
- Products that do not rise to the level of a Medical Device Reportable Event but that may indicate a device-related serious injury or malfunction; and
- Perform quarterly reviews of complaints, and if a subgroup of patients is identified that has a higher incidence of adverse events than the full patient population, determine the cause and alter promotional practices as appropriate.
This is the second settlement Attorney General Becerra has reached with Johnson & Johnson. In May 2017, Attorney General Becerra announced a $33 million settlement with the company after it failed to ensure the quality of over-the-counter medications including Tylenol, Motrin, Benadryl, St. Joseph Aspirin, Sudafed, Pepcid, Mylanta, Rolaids, and Zyrtec.
The settlement is subject to court approval. A copy of the complaint can be found here.
This article was released by the California Attorney General’s Office.